Enteral feeding safety reservoir and system

ABSTRACT

The present invention provides a one-piece bottle containing enteral feeding material and having a top end with a threaded section and a bottom end comprising a funneled connector port; and a threaded cap dimensioned to mate with the threaded section of the one-piece bottle; wherein the funneled connector port connects to an enteral feeding assembly; wherein the threaded cap provides a leak proof seal when tightened on the threaded section of the one-piece bottle, and allows venting of the bottle when loosened.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/294,976, filed Nov. 11, 2011, which is a continuation-in-part of U.S.patent application Ser. No. 12/028,736 filed Feb. 8, 2008, the contentsof which are incorporated herein by reference in their entireties.

FIELD OF THE INVENTION

The invention broadly relates to medical devices, systems and methodsand, more particularly, to enteral feeding systems and methods.

BACKGROUND OF THE INVENTION

Enteral feeding is a method of providing nutrition to a person or animalthat cannot or will not eat by swallowing. Enteral feeding may be donetemporarily, as may be the case for temporary or acute conditions, orindefinitely, as may be the case for chronic or uncurable conditions. Anenteral feeding system generally includes a container for holding thefeeding material and an apparatus for delivering the feeding material tothe patient. One of the major issues with enteral feeding iscontamination, as many of the persons or animals that are fed enterallyare in a distressed or immunocompromised state. Contamination can resultfrom various sources, but in many cases it results from exposure of thefeeding material to an external environment.

SUMMARY OF THE INVENTION

The present invention provides systems and methods for enteral feeding aperson or animal. In some embodiments, the systems of the presentinvention include a reservoir body configured to hold a reservoir liner,wherein the reservoir liner is configured to hold an enteral feedingmaterial; a reservoir connector configured to connect to the reservoirliner in a manner that permits flow of an enteral feeding material; areservoir cap configured to connect to the reservoir body in a mannerthat connects the reservoir connector to the reservoir liner disposedwithin the reservoir body; and a syringe adapter enteral feedingassembly having a distal end configured to connect to the reservoir capin a manner that permits flow of an enteral feeding material and aproximal end configured to connect to an enteral feeding device in amanner that permits flow of an enteral feeding material. In otherembodiments the reservoir liner is pre-filled with an enteral feedingmaterial and sealed. In some such embodiments the reservoir cap isconfigured to pierce or open the reservoir liner pre-filled with anenteral feeding material. In some embodiments the system also includesan enteral feeding device. In some such embodiments the enteral feedingdevice is selected from the group consisting of a nasogastric feedingtube, a gastric feeding tube, jejunostomy tube, and a gastrojejunostomytube. In certain embodiments the syringe adapter enteral feedingassembly is configured to connect only to an enteral feeding device. Insome embodiments the syringe adapter enteral feeding assembly isconfigured to connect only to enteral feeding elements.

In some embodiments, the systems of the present invention include areservoir body configured to hold a reservoir liner, wherein thereservoir liner is configured to hold an enteral feeding material; areservoir connector configured to connect to the reservoir liner in amanner that permits flow of an enteral feeding material and preventssubstantial exposure to an external environment; a reservoir capconfigured to connect to the reservoir body in a manner that permitsflow of an enteral feeding material and that connects the reservoirconnector to the reservoir liner disposed within the reservoir body in amanner that prevents substantial exposure to the external environment;and a syringe adapter enteral feeding assembly having a distal endconfigured to connect to the reservoir cap in a manner that permits flowof an enteral feeding material and prevents substantial exposure to theexternal environment, and a proximal end configured to connect to anenteral feeding device in a manner that permits flow of an enteralfeeding material and that prevents substantial exposure to the externalenvironment. In various embodiments the reservoir liner is pre-filledwith an enteral feeding material and sealed. In some such embodimentsthe reservoir cap is configured to pierce or open the reservoir linerpre-filled with an enteral feeding material. In certain embodiments thesystem also includes an enteral feeding device. In some such embodimentsthe enteral feeding device is selected from the group consisting of anasogastric feeding tube, a gastric feeding tube, jejunostomy tube, anda gastrojejunostomy tube. In certain embodiments the syringe adapterenteral feeding assembly is configured to connect only to an enteralfeeding device. In some embodiments the syringe adapter enteral feedingassembly is configured to connect only to enteral feeding elements.

In other embodiments the present invention is a method for delivering anenteral feeding material to a patient. In certain embodiments, themethod includes the use of a system as described herein. In someembodiments, the present invention is a method for delivering an enteralfeeding material to a patient, wherein the enteral feeding medium is notsubstantially exposed to an external environment. In some suchembodiments the methods includes the use of a system as describedherein.

In certain embodiments, the methods include the steps of providing areservoir body having a reservoir liner configured to hold an enteralfeeding material; providing a reservoir connector connected with thereservoir liner and a reservoir cap connected to the reservoir connectorand the reservoir body; providing a syringe adapter enteral feedingassembly having a proximal end connected to the reservoir liner via thereservoir connector and a distal end connected to an enteral feedingdevice; engaging the enteral feeding device with a patient in a mannerthat permits flow of the enteral feeding medium to a patient; andproviding the enteral feeding medium to the patient. In some embodimentsthe methods provide the enteral feeding medium to the patient withoutsubstantial exposure to the external environment. In other embodimentsthe methods provide the enteral feeding medium to the patient withoutexposure to the external environment.

In some embodiments, the enteral feeding system features a cappedreservoir comprising a one-piece bottle with no vent holes. The cappedreservoir includes a top end having a threaded section dimensioned tomate with a threaded cap. The threaded cap provides a leak proof sealwhen tightened on the threaded section of the bottle, and allows ventingof the bottle when loosened. Because the enteral feeding systemcomprises a closed system, venting is needed to allow the fluid to flow.The cap may be tethered to the bottle such that it is not misplaced. Thebottom end of the one-piece bottle terminates in a funneled connectorport, which may provide connections (e.g., through the use oral syringeconnectors) in a manner that is not compatible with IV connections. Theone-piece bottle and cap may be made from a suitable material such asplastic. The plastic may be clear, partially transparent, white, orange,purple, or any other suitable color. In certain embodiments, a standhaving a center hole for slidably receiving the one-piece bottle may beprovided for supporting the bottle in an upright position. the stand maycomprise a plurality of legs, or, alternatively, may comprising aone-piece mold.

In further embodiments, the one-piece bottle includes a cap having afiltered air vent port that may be selectively closed, for example,using a snap-fit seal. Alternatively, the selectively closable vent portmay be non-filtered. In some embodiments, the closable air vent port maybe located on the side of the bottle rather than on the cap. During use,the closable vent port provides air compensation when opened, andprovides a leak proof seal when closed. In embodiments featuring afiltered vent port, the air filter may or may not comprise a bacterialbarrier. By way of example, the filter may comprise a 0.2 micron filterfor air filtration providing significant bacterial protection.

In additional embodiments, the one-piece bottle includes a novel ventedcap that prevents bacteria from entering the bottle. The vented capallows the bottle to be filled with breast milk through the use of abreast pump that is attached to the cap in a leak proof manner. Thebottle may be connected—snapped or screwed on—to the breast pump andlater disconnected and recapped. Alternatively, the vented cap may bethreaded such that it may be loosened and removed from the bottle,thereby allowing a manual feed of either breast milk or other enteralfeeding solution, all without leakage. In manual feed embodiments, thecap may be tethered to the bottle such that it is not misplaced. Whenthe cap is removed, the breast milk or other enteral feeding solutionmay be poured directly into the bottle. Once capped, the bottle may bestored, frozen, and thawed with no exposure point until it is used forfeeding a baby. If no vent is provided, the cap may be cracked orloosened slightly in order to begin the flow of milk.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an embodiment of a system of thepresent invention.

FIG. 2 is an illustration of an embodiment of a reservoir body as may beused in an embodiment of the present invention.

FIG. 3 is an illustration of an embodiment of a reservoir liner as maybe used in an embodiment of the present invention.

FIG. 4A is a side view of an embodiment of a reservoir connector as maybe used in an embodiment of the present invention.

FIG. 4B is a view of the proximal end of an embodiment of a reservoirconnector as may be used in an embodiment of the present invention.

FIG. 5A is a side view of an embodiment of a reservoir cap as may beused in an embodiment of the present invention.

FIG. 5B is a view of the distal end of an embodiment of a reservoir capas may be used in an embodiment of a system of the present invention.

FIG. 6 is a schematic illustration of an embodiment of a syringe adapterenteral feeding assembly as may be used in an embodiment of a system ofthe present invention.

FIG. 7A illustrates a cross-sectional view of a capped reservoircomprising a one-piece bottle in accordance with the principles of theinvention.

FIG. 8A illustrates a cross-sectional view of a capped reservoircomprising a one-piece bottle including a vented cap (FIG. 8B) inaccordance with the principles of the invention.

FIG. 8C illustrates an alternative bottle cap having an RFID deviceattached thereto in accordance with the principles of the invention.

FIGS. 9A and 9B illustrate a perspective view of a modified cappedreservoir comprising a one-piece bottle having an oral syringeconnecting port in accordance with the principles of the invention.

FIG. 10A illustrates a perspective view of a stand for supporting theone-piece bottles of FIGS. 7-9 in accordance with the principles of theinvention.

FIG. 10B illustrates a perspective view of an alternative stand forsupporting the one-piece bottles of FIGS. 7-9 in accordance with theprinciples of the invention.

DETAILED DESCRIPTION

In the following paragraphs, the present invention will be described indetail by way of example with reference to the attached drawings.Throughout this description, the preferred embodiment and examples shownshould be considered as exemplars, rather than as limitations on thepresent invention. As used herein, the “present invention” refers to anyone of the embodiments of the invention described herein, and anyequivalents. Furthermore, reference to various feature(s) of the“present invention” throughout this document does not mean that allclaimed embodiments or methods must include the referenced feature(s).

Systems of the present invention have multiple elements and may includea combination of two or more of a reservoir body, a reservoir liner, areservoir connector, a reservoir cap, syringe adapter enteral feedingassembly, an enteral feeding device and any other compatible device orelement. The system of the present invention may include any suitablecombination of elements. The elements may be separate so long as theyare connectable to form a working system.

FIG. 1 illustrates an embodiment of the present invention havingreservoir body 100, reservoir liner 200, reservoir connector 300,reservoir cap 400, syringe adapter enteral feeding assembly 500, andenteral feeding device 600. FIG. 1 depicts the various elements of theembodiment of the system. In use, the elements may be connected in anysuitable manner. Preferably, each connection will not mate with standardintravenous administration couplings and/or connections. In someembodiments, each connection is unique such that it will only mateand/or connect with elements of an enteral feeding system. In otherembodiments, each connection prevents the enteral feeding material fromsubstantial interaction with an environment external to the system andthe patient. In various embodiments, each connection prevents theenteral feeding material from any interaction with the externalenvironment. In addition, in some embodiments one or more of theelements is disposable. In other embodiments, each element isdisposable.

FIG. 2 illustrates an embodiment of reservoir body 100. Reservoir body100 may be of any suitable size, shape and capacity and may be made ofany suitable material. Preferably, reservoir body 100 is made of a rigidmaterial. In some embodiments, reservoir body 100 is made of plastic andhas a capacity of about 10 ml to about 2000 ml. Preferably, reservoirbody 100 is generally cylindrical in shape, but it may have any suitableshape. Reservoir body 100 is generally hollow such that it defines anarea in which reservoir liner 200 may be disposed. Reservoir body 100has distal end 120 and proximal end 110. References to “proximal” and“distal” elements are made from the perspective of the patient (e.g.,reservoir body 100 is distal to enteral feeding device 600). Proximalend 110 may be open or closed. In some embodiments, proximal end 110includes connection structure 150. Connection structure 150 may be anystructure or substance that facilitates connection between reservoirbody 100 and reservoir cap 400. In the illustrated embodiment,connection structure 150 comprise threads that interact withcorresponding threads 480 on reservoir cap 400 to form a connection. Insome embodiments of the invention, distal end 120 is open. In variousembodiments, reservoir body 100 has measurement indicators 130 that showthe amount of material remaining within reservoir body 100.

FIG. 3 illustrates an embodiment of reservoir liner 200. Reservoir liner200 is configured to hold and dispense enteral feeding material and maybe of any suitable size, shape and capacity and may be made of anysuitable material. Preferably, reservoir liner 200 is non-rigid and madeof plastic. Reservoir liner 200 is configured to fit within reservoirbody 100. In preferred embodiments, reservoir liner 200 is substantiallycylindrical with a diameter smaller than the diameter of a substantiallycylindrical reservoir body 100. Reservoir liner 200 includes distal end220 and proximal end 210. In preferred embodiments, proximal end 210 hasa lip 250 around its circumference. Lip 250 may be made of the samematerial as the rest of reservoir liner 200 or it may be made of adifferent material. In preferred embodiments, lip 250 is sized andconfigured to contact proximal end 110 of reservoir body 100 whenreservoir liner 200 is disposed within reservoir body 100. In suchembodiments, lip 250 is also configured to contact distal end 320 ofreservoir connector 300. In some embodiments, reservoir liner 200 may bephysically attached to reservoir body 100. In other embodiments,reservoir liner 200 may be unitary with reservoir body 100. In variousembodiments, reservoir liner 200 is pre-filled with enteral feedingmaterial and sealed such that proximal end 320 is closed. In some suchembodiments, reservoir liner 200 is sealed using a material that may bepierced or opened as reservoir cap 400 is attached to reservoir body100.

FIGS. 4A and 4B illustrate an embodiment of reservoir connector 300.Reservoir connector 300 may be of any suitable size and shape and may bemade of any suitable material. In some embodiments, reservoir connector300 may be attached to or unitary with reservoir cap 400. In suchembodiments, the attachment may be made by any suitable method. In thedepicted embodiment, reservoir connector 300 has distal end 320 andproximal end 310. Distal end 320 is configured to contact reservoirliner 200 and/or reservoir body 100, whereas proximal end 310 isconfigured to connect with syringe adapter enteral feeding assembly 500.Preferably, reservoir connector 300 is made of a non-rigid material,such as rubber, and is tapered such that proximal end 310 has a diameteror area that is less than the diameter or area of distal end 320. In theillustrated embodiment, proximal end 310 has aperture 380 and is open atits distal end 320 such that enteral feeding material may enter throughdistal end 320 and pass through aperture 380. Additionally, distal end320 includes a lip 350 having a proximal surface 330 and a distalsurface 340. In some embodiments, lip 350 is generally circular, isdisposed around the circumference or edge of distal end 320 and is sizedand configured such that distal surface 340 will contact lip 250 ofreservoir liner 200 and proximal surface 330 will contact edge 460 ofreservoir cap 460. In some embodiments, proximal surface 330 of lip 350has annular groove 360 that is configured to mate with annular bump 440of reservoir cap 400. Reservoir connector 300 may have a structurecapable of piercing or opening a reservoir liner 200 that is pre-filledwith enteral feeding material and sealed at its proximal end 210.

FIGS. 5A and 5B illustrate an embodiment of reservoir cap 400. Reservoircap 400 may be any suitable size, shape and configuration and may bemade of any suitable material. Reservoir cap 400 is configured toconnect with reservoir body 100. In some embodiments, reservoir cap 400may be attached to or unitary with reservoir connector 300. In preferredembodiments, reservoir cap 400 is rigid and made of plastic. In thedepicted embodiment, reservoir cap 400 has proximal end 410 having edge460 and has distal end 420. In some embodiments, edge 460 is configuredto contact the proximal surface 330 of reservoir connector 300 whenreservoir cap 400 is connected to reservoir body 100. Preferably, edge460 has an annular bump 440 which mates with annular groove 360 ofreservoir connector 300. Also preferably, the distal end 310 ofreservoir connector passes through opening 450 such that distal end 310is connectable to additional elements, including syringe adapter enteralfeeding assembly 500. In preferred embodiments, the connection ofreservoir cap 400 to reservoir body 100 is made by interaction ofconnection structures 150 with threads 480. Preferably, the connectionof reservoir cap 400 to reservoir body 100 causes the distal end 320 ofreservoir connector 300 to contact lip 250 of reservoir liner 200.Accordingly, in some embodiments, the connection of reservoir cap 400 toreservoir body 100 secures reservoir liner 200 to reservoir body 200,secures reservoir connector 300 to reservoir liner 200 and securesreservoir connector 300 to reservoir cap 400, all in a manner thatpermits flow of an enteral feeding medium from reservoir liner 200 tothe distal end 310 of reservoir connector 300. In preferred embodiments,this connection is such that the enteral feeding medium is not exposedto the external environment. In some embodiments, reservoir cap 400 mayhave a structure capable of piercing or opening a reservoir liner 200that is pre-filled with enteral feeding material and sealed at itsproximal end 210.

FIG. 6 illustrates an embodiment of syringe adapter enteral feedingassembly 500. Syringe adapter enteral feeding assembly 500 may be anysuitable size and may be made of any suitable material and may havevarious combinations of elements. The depicted embodiment featuressyringe adapter 510, clamp 520, warning label 530, tubing 540, andconnection member 550. Syringe adapter 510 may be configured asdescribed in U.S. Design Pat. No. D542,406, which is hereby expresslyincorporated by reference in its entirety. Preferably, syringe adapter510 has a distal end 560 configured to connect to reservoir connector300 and a proximal end configured to connect to tubing 540. Distal end560 may connect to reservoir connector 300 in any suitable manner. Inpreferred embodiment's, distal end 560 may connect to reservoirconnector 300 in a manner that prevents exposure of the enteral feedingmedium to the external environment. Clamp 520 may be any suitable clamp.In some embodiments, clamp 520 may be a roller clamp or a slide clamp.Tubing 540 may be made of any suitable material and may have anysuitable width, length and thickness. In some embodiments, the tubes maybe made of plastic, polyurethane or silicone. In some embodiments,warning label 530 indicates that syringe adapter enteral feedingassembly 500 is to be used for enteral feeding only.

FIG. 6 also depicts an embodiment of enteral feeding device 600. Enteralfeeding device 600 may be any suitable device for any suitable method ortype of enteral feeding. Enteral feeding device 600 may also include aguide wire assembly to facilitate guiding the assembly into a patient.In some embodiments, enteral feeding device 600 is a nasogastric feedingtube passed through the nares, down the esophagus and into the stomach.In other embodiments, enteral feeding device 600 is a gastric feedingtube inserted through a small incision in the abdomen into the stomachand is used for long-term enteral nutrition. The gastric tube may be anytype of gastric tube, including a percutaneous endoscopic gastrostomytube or a gastronomy tube inserted in an open procedure. In yet otherembodiments, enteral feeding device 600 is a jejunostomy tube that isgenerally surgically inserted into the jejunum rather than the stomach.Enteral feeding device 600 may comprise a dual lumen gastrojejunostomytube. In some dual lumen embodiments one lumen is a gastric tube and thesecond lumen is a jujnal lumen. In such embodiments, the gastric lumenis used for decompression and the jejunal lumen is used to administerfeedings.

In some embodiments, the present invention is a method of providing apatient with an enteral feeding medium. The enteral feeding medium maybe any material suitable for enteral feeding a patient. Such methods mayinclude the use of a system as described herein in enteral feeding apatient. In some embodiments, the methods provide the enteral feedingmedium to a patient without substantial exposure of the enteral feedingmaterial to an external environment. Additionally, the methods mayprovide the enteral feeding medium to a patient without exposure to anexternal environment.

Referring to FIG. 7, a capped reservoir 700 is illustrated comprising aone-piece bottle 710 with no vent holes, a top end having a threadedsection 715 dimensioned to mate with a threaded cap 720, and a bottomend having a funneled connector port 730, which may provide connectionsto an enteral feeding assembly. By way of example, the funneledconnection port 730 may provide a connection to the syringe adapterenteral feeding assembly 500 and enteral feeding device 600 depicted anddescribed with respect to FIG. 1. For such embodiments, the one-piecebottle 710 is provided in lieu of the reservoir body 100 and reservoirconnector 300 of FIG. 1.

With further reference to FIG. 7A, the threaded cap 720 provides a leakproof seal when tightened on the threaded section 715 of the one-piecebottle 710, and allows venting of the bottle 710 when loosened. Becausethe enteral feeding system comprises a closed system, venting is neededto allow the fluid to flow. In some embodiments, the cap 720 may beattached to the bottle 710 using tether 740 such that it is notmisplaced. As stated, the bottom end of the one-piece bottle 710terminates in a funneled connector port 730, which may provideconnections (e.g., through the use oral syringe connectors) to anenteral feeding assembly in a manner that is not compatible with IVconnections. The one-piece bottle 710 and cap 720 may be made from anysuitable material. In some embodiments, one-piece bottle 710 is made ofplastic and has a capacity of about 10 ml to about 2000 ml. The bottlematerial may be clear, partially transparent, white, orange, purple, orany other suitable color. The one-piece bottle 710 illustrated in FIG.7A is generally cylindrical in shape, but it may have any suitableshape. In various embodiments, one-piece bottle 710 has measurementindicators that show the amount of material remaining within bottle 710.

In some embodiments, one-piece bottle 710 is generally hollow anddefines an area in which a reservoir liner 750 may be disposed. Thereservoir liner 750 may be configured to hold and dispense enteralfeeding material and may be of any suitable size, shape, capacity andmaterial. By way of example, reservoir liner 750 may be non-rigid andmade of plastic. In some embodiments, reservoir liner 750 issubstantially cylindrical with a diameter smaller than the diameter of asubstantially cylindrical one-piece bottle 710. Reservoir liner 750 maybe unitary with one-piece bottle 710. In various embodiments, reservoirliner 750 is sealed using a material that may be pierced or opened ascap 720 is attached to one-piece bottle 710.

With continued reference to FIG. 7A, the funneled connector port 730 ofone-piece bottle 710 may be of any suitable size and shape and may bemade of any suitable material. In some embodiments, funneled connectorport 730 includes a removable cap 760 on its bottom tip. In suchembodiments, the attachment may be made by any suitable method. In thedepicted embodiment, the top end of funneled connector port 730 isconfigured to contact reservoir liner 750 and/or one-piece bottle 710,whereas the bottom end is configured to connect with, for example, thesyringe adapter enteral feeding assembly 500 illustrated in FIG. 1.Funneled connector port 730 can be made of a non-rigid material, such asrubber, and is tapered such that its bottom end has a diameter or areathat is less than the diameter or area of its top end. The bottom end ofthe funneled connector port 730 includes an aperture 770 such thatenteral feeding material may pass through aperture 770 and into thesyringe adapter enteral feeding assembly 500.

Referring to FIGS. 8A and 8B, a capped reservoir 800 is illustratedcomprising a one-piece bottle 810, a top end having a threaded section815 dimensioned to mate with a threaded cap 820 having a filtered airvent port 825, and a bottom end having a funneled connector port 830,which may provide connections to an enteral feeding assembly. Similar tothe embodiment of FIG. 7, the funneled connection port 830 may provide aconnection to the syringe adapter enteral feeding assembly 500 andenteral feeding device 600 depicted and described with respect toFIG. 1. In some embodiments, the cap 820 may be attached to the bottle810 using tether 840 such that it is not misplaced.

In the illustrated embodiment, the threaded cap 820 includes filteredair vent port 825, which may be selectively closed, for example, using asnap-on seal 835 attached via a hinge 845 comprising an area of reducedthickness. In certain embodiments, the selectively closable vent port825 may be non-filtered. In some embodiments, the closable air vent port825 may be located on the side of the one-piece bottle 810 rather thanon the cap 820. During use, the closable vent port 825 provides aircompensation when opened, and provides a leak proof seal when closed. Inembodiments featuring a filtered vent port 825, the air filter may ormay not comprise a bacterial barrier. By way of example, the filter maycomprise a 0.2 micron filter for air filtration providing significantbacterial protection. The one-piece bottle 810 is generally hollow anddefines an area in which a reservoir liner 850 may be disposed. Like theembodiment of FIG. 7, the bottom end of the funneled connector port 830includes an aperture 870 such that enteral feeding material may passthrough aperture 870 and into the syringe adapter enteral feedingassembly 500. The funneled connector port 830 may include a removablecap 860 on its bottom tip.

In the embodiments of FIGS. 7 and 8, the one-piece bottle may include anovel vented cap that prevents bacteria from entering the bottle. Thevented cap allows the bottle to be filled with breast milk through theuse of a breast pump that is attached to the cap in a leak proof manner.Additionally, the cap may be removed and the bottle may then beconnected—snapped or screwed on—to the breast pump. In furtherembodiments, the vented cap may be threaded such that it may be loosenedand removed from the bottle, thereby allowing a manual feed of eitherbreast milk or other enteral feeding solution, all without leakage. Inmanual feed embodiments, the cap may be tethered to the bottle such thatit is not misplaced. When the cap is removed, the breast milk or otherenteral feeding solution may be poured directly into the bottle. Oncecapped, the bottle may be stored, frozen, and thawed with no exposurepoint until it is used for feeding a baby. If no vent is provided, thecap may be cracked or loosened slightly in order to begin the flow ofmilk. Referring to FIG. 8C, in some embodiments, an alternative cap 855may include an RFID tag 865 that is attached to the cap 855 via mountingpost 875. By way of example, the RFID tag 865 may be used formother/baby identification of appropriately matching breast milk.

Referring to FIGS. 9A and 9B, a modified capped reservoir 900 isillustrated comprising a one-piece bottle 910, a top end having aremovable threaded cap 920, and a bottom end having a funneled connectorport 930. An adapter comprising an oral syringe connecting port 940 isattached to the bottom end of the funneled connector port 930 such thatthe oral syringe connecting port 940, as an ID connection, may provideattachment to an oral syringe connector 950 of a syringe adapter feedingassembly 960. Specifically, the oral syringe connector 950 isdimensioned to slide into place within the oral syringe connecting port940, thereby providing fluid communication with the one-piece bottle910. FIG. 9A depicts the funneled connection port 930 connected withoral syringe stem connector 950, while FIG. 9B depicts the funneledconnection port 930 disconnected from oral syringe stem connector 950.The oral syringe connecting port 940 may be molded integral with theone-piece bottle 910, or may be a separate component that is mated withthe bottom end of the funneled connector port 930. In addition, the oralsyringe connecting port 940 may be clear plastic, or may have anysuitable color. The oral syringe stem connector 950 may comprise a clearstep connector, a colored step connector, or a molded single oralconnector, for example having an oral stem found on an oral syringe.

Referring to FIG. 10A, some embodiments of the invention include a stand1000 having a center hole 1010 for slidably receiving any of theone-piece bottles 710, 810, 910 of FIGS. 7-9. The stand 1000 is providedfor supporting a one-piece bottle 710, 810, 910 in an upright position.In the illustrated embodiment, the stand 1000 includes a bottle support1020 having center hole 1010 for receiving bottle 710, 810, 910, and aplurality of legs 1030 for supporting the bottle support 1020. The legs1030 may be attached to the bottle support 1020 in any suitable fashion,such as using threaded fasteners 1040.

Referring to FIG. 10B, in further embodiments the stand may alsocomprise a one-piece mold 1050 having a base 1060 and two upwardlyextending members 1070 forming a slot 1080 therebetween for receivingthe bottle 710, 810, 910 and allowing the tubing to pass through theslot 1080. The slot 1080 is preferably tapered such that the bottle 710,810, 910 slides into the slot 1080 before becoming wedged between thetwo members 1070.

Thus, it is seen that enteral feeding systems and methods are provided.One skilled in the art will appreciate that the present invention can bepracticed by other than the various embodiments and preferredembodiments, which are presented in this description for purposes ofillustration and not of limitation, and the present invention is limitedonly by the claims that follow. It is noted that equivalents for theparticular embodiments discussed in this description may practice theinvention as well.

While various embodiments of the present invention have been describedabove, it should be understood that they have been presented by way ofexample only, and not of limitation. Likewise, the various diagrams maydepict an example configuration for the invention, which is done to aidin understanding the features and functionality that may be included inthe invention. The invention is not restricted to the illustratedexample configurations, but the desired features may be implementedusing a variety of alternative configurations. Indeed, it will beapparent to one of skill in the art how alternative functional, logicalor physical configurations may be implemented to implement the desiredfeatures of the present invention. Also, a multitude of differentconstituent part names other than those depicted herein may be appliedto the various parts. Additionally, with regard to method claims, theorder in which the steps are presented herein shall not mandate thatvarious embodiments be implemented to perform the recited functionalityin the same order unless the context dictates otherwise.

Although the invention is described above in terms of various exemplaryembodiments and implementations, it should be understood that thevarious features, aspects and functionality described in one or more ofthe individual embodiments are not limited in their applicability to theparticular embodiment with which they are described, but instead may beapplied, alone or in various combinations, to one or more of the otherembodiments of the invention, whether or not such embodiments aredescribed and whether or not such features are presented as being a partof a described embodiment. Thus the breadth and scope of the presentinvention should not be limited by any of the above-described exemplaryembodiments.

Terms and phrases used in this document, and variations thereof, unlessotherwise expressly stated, should be construed as open ended as opposedto limiting. As examples of the foregoing: the term “including” shouldbe read as meaning “including, without limitation” or the like; the term“example” is used to provide exemplary instances of the item indiscussion, not an exhaustive or limiting list thereof; the terms “a” or“an” should be read as meaning “at least one,” “one or more” or thelike; and adjectives such as “conventional,” “traditional,” “normal,”“standard,” “known” and terms of similar meaning should not be construedas limiting the item described to a given time period or to an itemavailable as of a given time, but instead should be read to encompassconventional, traditional, normal, or standard technologies that may beavailable or known now or at any time in the future. Likewise, wherethis document refers to technologies that would be apparent or known toone of ordinary skill in the art, such technologies encompass thoseapparent or known to the skilled artisan now or at any time in thefuture.

A group of items linked with the conjunction “and” should not be read asrequiring that each and every one of those items be present in thegrouping, but rather should be read as “and/or” unless expressly statedotherwise. Similarly, a group of items linked with the conjunction “or”should not be read as requiring mutual exclusivity among that group, butrather should also be read as “and/or” unless expressly statedotherwise. Furthermore, although items, elements or components of theinvention may be described or claimed in the singular, the plural iscontemplated to be within the scope thereof unless limitation to thesingular is explicitly stated.

The presence of broadening words and phrases such as “one or more,” “atleast,” “but not limited to” or other like phrases in some instancesshall not be read to mean that the narrower case is intended or requiredin instances where such broadening phrases may be absent. The use of theterm “module” does not imply that the components or functionalitydescribed or claimed as part of the module are all configured in acommon package. Indeed, any or all of the various components of amodule, whether control logic or other components, may be combined in asingle package or separately maintained and may further be distributedacross multiple locations.

Additionally, the various embodiments set forth herein are described interms of exemplary block diagrams, flow charts and other illustrations.As will become apparent to one of ordinary skill in the art afterreading this document, the illustrated embodiments and their variousalternatives may be implemented without confinement to the illustratedexamples. For example, the figures and their accompanying descriptionshould not be construed as mandating a particular configuration.

1. An apparatus, comprising: a one-piece bottle containing enteralfeeding material and having a top end with a threaded section and abottom end; and a threaded cap dimensioned to mate with the threadedsection of the one-piece bottle; wherein the threaded cap provides aleak proof seal when tightened on the threaded section of the one-piecebottle, and allows venting of the bottle when loosened.
 2. The apparatusof claim 1, wherein the bottom end comprises a funneled connector portthat connects to an enteral feeding assembly.
 3. The apparatus of claim1, wherein the one-piece bottle is made of plastic and has a capacity of50 ml to 2000 ml.
 4. The apparatus of claim 1, further comprising areservoir liner disposed within the one-piece bottle.
 5. The apparatusof claim 4, wherein the reservoir liner is integral with the one-piecebottle.
 6. The apparatus of claim 5, wherein the reservoir liner issealed using a material that is pierced as the cap is attached to theone-piece bottle.
 7. The apparatus of claim 2, wherein the funneledconnector port is made of a non-rigid material, and is tapered such thatits bottom end has a diameter that is less than a diameter of its topend.
 8. The apparatus of claim 7, wherein the bottom end of the funneledconnector port includes an aperture such that enteral feeding materialmay pass through aperture and into the enteral feeding assembly.
 9. Anapparatus, comprising: a one-piece bottle containing enteral feedingmaterial and having a top end with a threaded section and a bottom end;and a threaded cap having a filtered air vent port and dimensioned tomate with the threaded section of the one-piece bottle; wherein thethreaded cap provides a leak proof seal when tightened on the threadedsection of the one-piece bottle, and allows venting of the bottle whenloosened.
 10. The apparatus of claim 9, wherein the bottom end comprisesa funneled connector port that connects to an enteral feeding assembly.11. The apparatus of claim 10, wherein the filtered air vent port isselectively closable using a snap-on seal attached via a hingecomprising an area of reduced thickness.
 12. The apparatus of claim 11,wherein the filtered air vent port provides air compensation whenopened, and provides a leak proof seal when closed.
 13. The apparatus ofclaim 9, wherein the filtered vent port includes a 0.2 micron air filtercomprising a bacterial barrier.
 14. The apparatus of claim 10, whereinthe bottom end of the funneled connector port includes an aperture suchthat enteral feeding material may pass through the aperture and into theenteral feeding assembly.